Ikcon Investments, Inc dba Ikcon Medical

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The Akcutest Kit and the Lumigenik Kit are offered for sale in the United States without marketing approval, clearance, or authorization from FDA.

Passage 2

Accordingly, the products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 3

The products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 4

The Akcutest Kit is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to an establishment registration that create an impression of official FDA approval of the establishment or its products are misleading and constitute misbranding. See 21 CFR 807.39. Your websites reference FDA registration (e.g., “FDA registered”), at times incorporating unauthorized use of the FDA logo